FDA Rejects MDMA For PTSD Treatment, Calls For More Research On Psychedelic Therapy

The Food and Drug Administration (FDA) this week declined to approve the use of MDMA — popularly known as Ecstasy or Molly — for MDMA-assisted therapy for treating PTSD, disappointing many Americans who suffer with intractable mental health conditions and had pinned their hopes on the treatment.

There are only two FDA-approved treatments for PTSD, and MDMA would be the first to come on the market in decades. Friday's decision comes at a time when there is growing interest in the use of alternative drugs to treat various mental health conditions, including depression and anxiety.

Though MDMA has long been associated with recreational use, its potential therapeutic benefits have garnered significant attention in recent years. Before its prohibition in 1985, MDMA was frequently used by psychotherapists to aid patients in addressing profound trauma.

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Lykos Therapeutics, the research arm of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), indicated that the FDA’s refusal was due to “insufficient data.” The regulatory body demanded another clinical trial to verify the safety and effectiveness of MDMA. Approval would have marked MDMA as the first psychedelic drug sanctioned for therapeutic use by the federal government.

"The FDA request for another study is deeply disappointing," said Lykos CEO Amy Emerson in a statement. "Our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse and countless others suffering from PTSD who may now face more years without access to new treatment options."

Rick Doblin, PhD, founder and president of MAPS noted that the organization has been engaged in FDA-approved research of MDMA-assisted therapy for nearly 40 years and will continue despite this setback.

"MAPS will continue working towards safe, legal access to this therapy for the more than 350 million people living with PTSD worldwide," Doblin stated in an email shared with Benzinga. "MAPS remains fully focused on supporting culturally appropriate research, rigorous science, and drug policy reform that empowers citizen advocacy in all areas of the world including those with high incidences of trauma and limited resources."

Though classified as a Schedule I drug, the FDA granted MDMA “breakthrough therapy” in 2017. Since then, several studies have been carried out with positive results. Lykos Therapeutics reported that  71% of participants had their PTSD diagnosis eliminated after undergoing the second stage of the trials.

This past June, an FDA panel disapproved Lykos’s application due to what it deemed an inadequacy in demonstrating the treatment’s effectiveness and an imbalance in risk over potential benefit.

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Photo courtesy of FDA